Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
Recruiting
Phase 2
Interventional Study
Advanced or Metastatic Melanoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 45 (estimated)
- Sponsor
- Hanmi Pharmaceutical Company Limited · Industry
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About This Trial
This is a Phase 2 open-label, multicenter, single-arm study evaluating the combination of Belvarafenib and Cobimetinib in patients with locally advanced or metastatic melanoma with NRAS mutations. The study plans to assess ORR, DCR, DOR, TTP, PFS, OS and safety of the participating subjects.
Treatment cycles for all subjects will be 28 days in duration and Belvarafenib and Cobimetinib will be adm…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Have histologically, cytologically confirmed locally advanced or metastatic melanoma for which no adequate standard of care exists, or for which standard of care has failed or is not tolerated.
* Have NRAS mutation.
* Have at least one measurable lesion at baseline per REC…
Contacts